Aziyo Launches CanGaroo Bio Envelope for Subcutaneous Implantable Cardioverter-Defibrillators

Aziyo Biologics Inc., a fully integrated regenerative medicine company, has launched a new CanGaroo Bio Envelope specifically for use with subcutaneous implantable cardioverter-defibrillators (S-ICDs). This is the only cardiac implantable electronic device (CIED) envelope available for use with S-ICDs.
 
CanGaroo is a natural extracellular matrix (ECM) scaffold that is intended to securely hold CIEDs to create a stable environment following implantation. Studies have demonstrated that use of CanGaroo when implanting CIEDs reduces the risk of device migration and erosion and may facilitate device removal when future exchange or revision is required. The larger size and unique design of this new envelope expands the CanGaroo product line from four to five sizes to allow for use in securing larger subcutaneous devices.
 
“Creation of a natural regenerative implantation environment and preserving defibrillation threshold vectors with a stable shock impedance are challenging complications for patients undergoing implantation of S-ICDs,” said John N. Catanzaro, M.D. FACC, FESC, FHRS electrophysiologist at the University of Florida-Jacksonville. “The availability of a bio envelope large enough to secure the S-ICD is of paramount importance for the potential to achieve effective defibrillation.”
 
“A number of different challenges are associated with the implantation of subcutaneous ICDs versus traditional transvenous ICDs due to device location and placement,” said Patrick Ferguson, vice president of sales at Aziyo Biologics. “Our bio envelope is specifically designed to complement the subcutaneous implant experience providing long-term pocket health and vector stabilization.”
 
The CanGaroo Bio Envelope is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa (SIS). Once implanted, CanGaroo secures the CIED in place, and evidence shows that over time it remodels into a vascularized pocket that may facilitate CIED removal or revision. CanGaroo Bio Envelope is a 510(k) U.S. Food and Drug Administration (FDA)-cleared medical device.
 
Porcine SIS is a decellularized matrix that serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM is gradually replaced as the patient’s own cells restore the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. Since 1999, an estimated 2 million patients worldwide have received SIS ECM implants.
 
About Aziyo Biologics is a fully integrated regenerative medicine company formed by HighCape Partners, Deerfield Management Co. and KeraLink International. Aziyo is transforming regenerative medicine by combining a portfolio of cardiac and orthopedic products with deep commercial expertise to build value. The commercial and pipeline products include FDA-cleared medical devices and human tissue-based products for surgical implantation.